MUSTANG™ H74939171060670Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 08714729793762), received between Oct 3, 2019 and Sep 21, 2026 — classified as 1 injury, 39 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (34 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Material Rupture

  It was reported that balloon burst occurred.The stenosed target lesion was located in the arteriovenous fistula. A 6.0 x 60, 75cm Mustang balloon catheter was advanced for dilation. During the procedure, it was noted that the balloon burst. The procedure was completed with another of same device. There were no patient complications as a result of this event, and the patient was stable post-procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50836660 ↗
• MalfunctionAug 18, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50306530 ↗
• MalfunctionMay 18, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. ON (B)(6) 2026, THE PATIENT UNDERWENT RIGHT UPPER LIMB ANGIOGRAPHY AND BALLOON DILATION FOR AN ARTERIOVENOUS FISTULA. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS, NON-CALCIFIED RIGHT UPPER LIMB VESSEL. A 6.0 X 60, 75 CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING DILATION OF THE STENOTIC SEGMENT, BLOOD WAS OBSERVED IN THE INFLATION DEVICE, AND THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW 7 MM X 60 MM MUSTANG BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25200033 ↗
• MalfunctionMay 13, 2026Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23APRIL2026. IT WAS REPORTED THAT BALLOON ISSUES OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ARTERIOVENOUS FISTULA. A 6.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE THE BALLOON WAS LEAKING LIQUID DURING THE SECOND DILATION AND COULD NOT BE FULLY INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON RUPTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161362 ↗
• MalfunctionApr 15, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 6.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SECOND INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24890504 ↗
• MalfunctionMar 15, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 6.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24602121 ↗
• MalfunctionMar 9, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS BEING TREATED FOR STENOSIS AND WAS TO UNDERGO FISTULOPLASTY. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MILDLY TORTUOUS LEFT BRACHIOCEPHALIC FISTULA. A 6.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 16 ATMOSPHERES FOR LESS THAN 1 MINUTE, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PATIENT WAS FULLY RECOVERED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24551739 ↗
• MalfunctionJan 20, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT FOREARM ARTERIOVENOUS FISTULA. A 6.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 18 ATMOSPHERES FOR 25 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24122171 ↗
• MalfunctionJan 20, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. PATIENT WAS UNDER LOCAL ANESTHESIA. THE TARGET LESION WITH REFRACTORY STENOSIS AND VASCULAR CALCIFICATION WAS LOCATED IN THE LEFT FOREARM ARTERIOVENOUS FISTULA. A 6.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION AT 18 ATMOSPHERES, THE BALLOON RUPTURED. NO FRAGMENTS WERE FOUND. THE BALLOON WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THE PATIENT EXPERIENCED NO SIGNIFICANT DISCOMFORT. POSTOPERATIVE BLOOD FLOW IMPROVED, AND HEMODIALYSIS PROCEEDED SMOOTHLY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24115449 ↗
• MalfunctionDec 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE THROMBUS RADIAL CEPHALIC AREA. A 6.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS RUPTURE AFTER INFLATED FEW TIMES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850544 ↗
• MalfunctionDec 8, 2025Inflation Problem; Nonstandard Device; Inflation Problem; Nonstandard Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21NOV2025. IT WAS REPORTED THAT BALLOON POOR RE-WRAP OCCURRED. THE TARGET LESION WAS LOCATED IN THE CHALLENGING ARTERIOVENOUS FISTULA. A 6.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON DID NOT INFLATE WELL IN THE LESION AND IT WAS POORLY RE-WRAP. THE BALLOON WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A LONGITUDINAL TEAR WAS IDENTIFIED IN THE BALLOON MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23745704 ↗
• MalfunctionDec 1, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 6.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON BURST. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23678054 ↗
• MalfunctionNov 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SHUNT WITHIN SEVERELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 6.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 1 SECOND, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT STRONG CALCIFICATION WAS PRESENT, WHICH HAS INFLUENCED THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638983 ↗
• MalfunctionNov 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0 X 60,75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING PROCEDURE, THE BALLOON WAS POPPING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATION AS THE RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526640 ↗
• MalfunctionNov 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0 X 60,75 CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. THE BALLOON WAS POPPING. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE 100% STENOSED TARGET LESION IS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ARTERIOVENOUS FISTULA (AVF). THE PATIENT CONDITION WAS VERY GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23522112 ↗
• MalfunctionSep 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60-70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED BRACHIOCEPHALIC FISTULA ANASTOMOSIS. A 6.0 X 60, 75CM MUSTANG BALLOON WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING INFLATION, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935185 ↗
• MalfunctionAug 5, 2025Material Rupture; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Material Rupture; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE RADIAL CEPHALIC VEIN. A 6.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER BEING INFLATED TWICE AT 24 ATMOSPHERES, AND THE WIRE ALSO BECAME DETACHED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720842 ↗
• MalfunctionSep 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE VENOUS FISTULA. A 6.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON WAS FAILED TO DILATE AND THE BALLOON WAS RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LESION. THE BALLOON WAS RUPTURED AFTER THE 2 - 3 TIMES INFLATION AT 24 ATMOSPHERES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20198540 ↗
• MalfunctionMay 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED ARTERIOVENOUS FISTULA. A 6.0 X 60, 75CM MUSTANG BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19366603 ↗
• MalfunctionApr 11, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT SLOW DEFLATION ON THE BALLOON OCCURRED. THE PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND VERY SEVERELY CALCIFIED ARTERIOVENOUS FISTULA. A 6.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEFLATION TIME WAS TOO SLOW. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19090343 ↗
• MalfunctionFeb 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT FOREARM ARTERY. A 6.0 X 60, 75CM MUSTANG WAS ADVANCED FOR DILATION. DURING PREPARATION, IT WAS FOUND THAT THE BALLOON BURSTS WHEN FLUSHING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18686761 ↗
• MalfunctionJan 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE NON-TORTUOUS AND SEVERELY CALCIFIED VESSEL IN THE FOREARM. A 6.0 X 60, 75CM MUSTANG CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 22 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18536036 ↗
• MalfunctionJan 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON WAS BROKEN. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED UPPER EXTREMITY VEIN. A 6.0 X 60, 75CM MUSTANG BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 16 KPA (KILOPASCAL) FOR 1 MINUTE, THE BALLOON WAS BROKEN. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18447573 ↗
• MalfunctionNov 13, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED ARTERIOVENOUS FISTULA. A 6.0 X 60, 75-CM MUSTANG BALLOON CATHETER WAS USED FOR DILATION. THE PATIENT WAS UNDERGOING DIALYSIS; HOWEVER, THE PHYSICIAN COULDN'T DEFLATE THE BALLOON. THE PHYSICIAN REMOVED THE BALLOON PHYSICALLY, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO FURTHER ISSUES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18125233 ↗
• MalfunctionNov 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RADIAL ARTERY. A 6.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE THIRD INFLATION AT 24 TO 26 ATMOSPHERES FOR 30 TO 60 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18072729 ↗